Beta-blockers in i-PAH

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The main question of this study is: 'Is selective beta-blocker treatment safe and effective in reducing sympathetic overdrive, thereby improving RV function and remodeling in patients with iPAH?'.

In addition to the determination of RVEF, the investigators will explore how beta-blocker therapy affects sympathetic overdrive, remodeling of the RV, single beat elastance, exercise capacity and mechanical efficiency.

30 iPAH patients will be randomized to either Bisoprolol- or placebo-treatment in a double-blinded fashion. A cross-over trial design will be used to increase the power of the study and to assess long-term effects of Bisoprolol-treatment and -withdrawal. The medication will be given in an escalating dose regimen (as described in the 'farmacotherapeutisch kompas', www.fk.cvz.nl) and treatment will be monitored along the guidelines of the American Heart Association.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Adrenergic beta-Antagonists; Bisoprolol

Criteria

Inclusion Criteria:

• Idiopathic PAH patients

• Stable on PAH specific treatment defined

• No change in PAH specific treatment in the past 6 months

• No change in functional class in the past 6 months

• <10 % change in 6 minute walk distance in the past 6 months

• Functional class 2 or 3

• In sinus rhythm

Exclusion Criteria:

• History of systemic hypertension, ischaemic heart disease, valvular disease or cardiomyopathy.

• Asthma

• Use of concomitant medication other than diuretics, Acenocoumarol and PAH targeted therapy

• History of cardiac arrhythmias or the use of anti-arrhythmic drugs

• Sick sinus syndrome

• systolic hypotension < 90 mmHg

• AV-block

• Clinically relevant sinus-bradycardia